Registry on the EXperience of Extracorporeal CO2 Removal in Intensive Care Units

• Conditions: Patients With Acute Respiratory Distress Syndrome; Patients With Acute Exacerbation of Chronic Obstructive Pulmonary Disease

• Registration Number: NCT02965079
• Lead Sponsor: Rexecor

Brief Summary

Investigators will aim to conduct an observational study in order to assess very thoroughly all patients implanted by Extracorporeal carbon dioxide removal (ECCO2R) in 10 critical care units of Paris and its surburb (APHP, Assistance Publique des hôpitaux de Paris).

Secondary objectives will be:

1. to assess efficacy and safety of ECCO2R,

2. to compare the data issue from the registry to others studies assessing the same population and to other centers and

3. to compare the different ECCOR devices in terms of efficacy and adverse events.

Detailed Description

The registry will be conducted prospectively during 2 years in 10 ICUs of l'APHP on behalf on the CEDIT. The 10 centers are : (1) ICU of l'hôpital europeén Georges Pompidou, (2) ICU of l'Hôpital Louis Mourier, (3) ICU of l'Hôpital de Bicêtre, (4) ICU of GHPS, (5) Respiratory ICU of GHPS, (6) ICU of l'Hôpital Lariboisière (7) ICU of l'Hôpital Cochin (8) ICU of l'Hôpital Saint-Antoine (9)ICU of l'Hôpital Henri Mondor and (10) ICU of l'Hôpital Tenon.

The primary outcome will be the number of patients implanted by ECCO2R monthly in each center during the 2 years period study.

Secondary outcomes will be ICU-mortality, invasive ventilation duration, non invasive ventilation duration, ICU duration, modalities of ventilation at the ICU discharge, hemorragic complications due to the ECCOR device, thrombotic complications due to ECCO2R device, intravascular hemolysis due to ECCO2R device, duration of ECCO2R, adjunct therapy to ECCO2R and reasons of ECCO2R discontinuation.

Study Timeline

• Study Start: 2016-01
• Study First Submitted: 2016-11-09
• Study First Submitted QC: 2016-11-11
• Study First Posted: 2016-11-16
• Status Verified: 2020-09
• Last Update Submitted: 2020-10-11
• Last Update Posted: 2020-10-14
• Primary Completion: 2022-01
• Study Completion: 2022-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• Patients implanted with ECCCO2R

Exclusion Criteria

• Contra-indication to ECCO2R

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence of ECCO2R use	Recorded monthly up to 100 weeks (24 months)	Number of ECCO2R implantation monthly by center

Secondary Outcome Measures

Name	Time	Method
Duration of mechanical ventilation	Recorded from ICU admission until the date of death or ICU discharge,assessed up to 100 weeks
ICU mortality	Recorded From date of ICU admission until the date of death or ICU discharge, assessed up to 100 weeks
ICU duration	Recorded from ICU admission until the date of death or ICU discharge,assessed up to 100 weeks
Ventilation modalities at discharge	Recorded from the initiation of ventilation until ventilation removal,assessed up to 100 weeks
hemorragic and thrombotic complications	Recorded from the date of ECCO2R implantation until the removal of the device,assessed up to 100 weeks
hemolysis	Recorded from the date of ECCO2R implantation until the removal of the device,assessed up to 100 weeks

Trial Locations

Locations (1)

Assistance Publique - Hopitaux de Paris; 🇫🇷 Paris, France